Allergan, the makers of Botox and other cosmetic surgery treatments, has recently been approached the U.S. Food and Drug Administration about its marketing and advertising campaign of Aczone, an acne treatment that was announced for the U.S. markets earlier this year.
According to a recent report in the Los Angeles Business Journal, the U.S. Food and Drug Administration is claiming that the ads are misleading and that Aczone’s effectiveness is overstated.
The print advertisements ran in magazines and newspapers in Spring 2009 and did not appear again later this year. However, the marketing and advertising campaign did not include information about the (many) risk factors associated with the Aczone treatment, and as a result, Allergan is no longer allowed to run the same ad.
Azone is promoted as a topical gel acne medication that can be prescribed by a dermatologist. Free samples of the product are available online by visiting and filling out a registration form. The current ads on the website claim that Aczone can produce results in as little as two weeks, and is a “highly effective way to treat acne.”
The safety and side effects section of the website reports that women who are pregnant or are planning to become pregnant, women who are breastfeeding, and individuals who have glucose-6 phosphate dehydrogenase (G6PD) deficiency should not use the product and must consult with a medical doctor before pursuing this type of treatment. According to Allergan, Aczone may not be a good match for those who are taking acne medication with benzoyl perozxide.
Side effects of Aczone include redness, oiliness and peeling of the skin, and if the patient uses benzoyl peroxide in conjunction with the Aczone gel, the skin can turn yellow or orange.
These side effects were omitted from the marketing and adveritsing campaign that Allergan ran this spring.
Allergan has been issued a warning and must send a written response to the FDA by August 28, 2009 before the FDA pursues legal action.